COULTER AC.T SERIES ANALYZER— 510(k) K964988

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K964988 for COULTER AC.T SERIES ANALYZER, Substantially Equivalent on 1997-03-06. Applicant: Coulter Corp..

Clearance details

Applicant: Coulter Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1996-12-13
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.